Director of Clinical Operations, Gene Therapy

3 weeks ago

California, United States Insmed Incorporated Full time



Company Description

About Insmed

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.



Recognitions

Named Science's Top Employer in 2021, 2022, and 2023

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in BiopharmaTM, Best Workplaces in New YorkTM, and Best Workplaces for MillennialsTM lists.



Overview

The primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and ensuring compliance with Good Clinical Practices as well as federal and local laws.



Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

Provide management across multiple studies and clinical operations aspects of gene therapy programs.Responsible for the development of, and the oversight for execution of clinical studies milestones to support company budgets, and quality standards.Ensure the clinical department follows appropriate guidelines as it relates to Good Clinical Practices as well as federal and local laws processes and procedures.Maintain good communication with other departments to foster strong relationships in connection with matters related to clinical projects.Manage and participate in developing and drafting protocols, forms, investigator brochures, clinical study reports and other documents as needed.Manage and development of systems, practices, and procedures to ensure efficient and effective clinical trial execution including data management and analysis.Build and maintain relationships with KOLs and investigators to foster strong partnerships.Develop and maintain appropriate metrics to assess performance, compliance and cost effectiveness.Leads investigator meetings, kick-off meetings, monitoring training and various CRO (or other vendor) meetings.Presents trial status and clinical operations strategy to project team and management.Reviews and approves specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.Leads Clinical Sub-team meetings.Approves action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.Job Requirements:Bachelor's degree required. Advanced degree preferred.Minimum of 10 years managing clinical trials at a Sponsor company.Experience managing various phases of clinical trials.Experience in global clinical trial conduct across several therapeutic areas is desired.Experience in rare disease and/or orphan indications is preferred.Experience managing the finances of clinical trials, including budgeting, forecast, accruals and invoicing.Experience in vendor and laboratory selection, set-up, and management is required.Participation in NDA/sNDA filing is preferred.Must have excellent communication skills (verbal and written).Possess critical thinking skills for problem solving, conflict resolution, collaboration, interpretation and leadership tasks.Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.Must successfully exhibit Insmed's five (5) core corporate values of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.Domestic and/or international travel required up to 30%

Travel Requirements

Up to 20% travel



Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $179,000.00 to $250,800.00 per year



Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

Flexible approach to where and how we work, regionally basedCompetitive compensation package including bonus Stock options and RSU awardsEmployee Stock Purchase Plan (ESPP)Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS:401(k) plan with company matchMedical, dental, and vision plansCompany-provided Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance Program (EAP)Mental Health on-line digital resourceWell-being reimbursementPaid leave benefits for new parentsPaid time off to volunteerOn-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

#LI-KM1

#LI-Hyrbid

  • Director/Sr. Director, Clinical Pharmacology

    1 month ago

    California, United States Arrowhead Pharmaceuticals, Inc. Full time

    Director/Sr. Director, Clinical Pharmacology & Pharmacometrics Office Location: Madison, WI or Pasadena, CA or San Diego, CA Director/Sr. Director, Clinical Pharmacology & Pharmacometrics Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes...

  • Director of Therapy Operations

    4 weeks ago

    Stockton, California, United States Ernest Health Full time

    Overview:At Stockton Regional Rehabilitation Hospital, we are passionate about patient care At our 50-bed hospital, we provide specialized inpatient and outpatient rehabilitative services to our patients, serving Stockton and surrounding areas. We see patients who often are recovering from disabilities caused by injuries, illnesses, or chronic medical...

  • Director Clinical Operations

    4 weeks ago

    California, United States BioPhase Full time

    Hybrid Position | Located in San Diego, CA This Director of Clinical Operations will play a pivotal role in leading and supervising all activities related to clinical operations, including the management and execution of clinical trials in accordance with Good Clinical Practices (GCP) as well as in compliance with various governing regulatory agencies. This...

  • Clinic Director

    3 weeks ago

    Desert Hot Springs/California/US All Star Physical Therapy Full time

    Overview:  up to a $30K In Sign-on Bonuses and Career Development! 10K Sign On Bonus    Clinic Director - Outpatient All Star Physical Therapy is a part of the Confluent Health family of outpatient physical and occupational therapy companies. We are taking the physical therapy industry by storm with our innovative career development options, including...

  • Director, Business Development

    1 month ago

    California, United States Worldwide Clinical Trials - USA Full time

    Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on...

  • Director, Business Development

    1 month ago

    California, United States Worldwide Clinical Trials - USA Full time

    Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on...

  • Executive Medical Director, Ophthalmology

    1 day ago

    California, United States Insmed Incorporated Full time

    Company DescriptionAbout Insmed Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world...

  • LMFT Clinical Program Director

    2 weeks ago

    California, United States Sevita Full time

    Mentor Community Services , a part of the Sevita family, provides community-based services for individuals with intellectual and developmental disabilities. Here we believe every person has the right to live well, and everyone deserves to have a fulfilling career. You'll join a mission-driven team and create relationships that motivate us all every day. Join...

  • Director of Business Development

    1 week ago

    California, United States Michael Page Full time

    About Our Client Renowned for its excellence in Biologics, Small Molecules/APIs, Clinical Research, Bioanalytical Sciences, DMPK, Cell and Gene Therapy, and more, my client has built a stellar reputation through exceptional service, fostering repeat business. While their large molecule bioanalytical team is based on the East Coast, candidates from across the...

  • Director Study Leader

    4 weeks ago

    California, United States Neogene Therapeutics Full time

    At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a...

  • Director, Operations

    4 weeks ago

    California, United States Sonrava Health Full time

    Our Company is looking for a bright, motivated District Manager (Practice Development Manager). The Practice Development Manager will lead a region of our offices with the primary responsibility of ensuring financial, operating and patient care excellence. This position has accountability for key financial and operating results within the region and is...

  • Physician Clinic Medical Director

    4 weeks ago

    Moreno Valley, California, United States Concentra Full time

    Overview:Looking for a Physician Leadership role in Moreno Valley, CA?Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient care team and play a crucial role in providing exceptional care to our patients. Our mission is to improve the health of America's workforce, one patient at a time. Join us at...

  • Clinical Director

    3 weeks ago

    California, United States Crestwood Behavioral Health Full time

    Title:Clinical Director Job Duties: The Clinical Director directs and coordinates the rehabilitation program. The Clinical Director ensures compliance with established policies and procedures of the overall program and timely completion of respective reporting requirements. Education Loan Assistance Program Available Schedule:Full–Time Qualifications: ...

  • Director/Senior Director, Clinical Pharmacology

    4 weeks ago

    California, United States Lumicity Full time

    Lumicity is collaborating with two biotech companies based in California, both aiming to expand their Clinical Pharmacology teams by recruiting new Directors.The first company concentrates on autoimmune diseases and cancer, seeking a strategic Clinical Pharmacologist.The second company, specialized in oncology, requires an expert pharmacometrician to lead...

  • Director of Business Development

    1 week ago

    California, United States Michael Page Full time

    About Our Client Renowned for its excellence in Biologics, Small Molecules/APIs, Clinical Research, Bioanalytical Sciences, DMPK, Cell and Gene Therapy, and more, my client has built a stellar reputation through exceptional service, fostering repeat business. While their large molecule bioanalytical team is based on the East Coast, candidates from across the...

  • Director, Governance Operations

    2 weeks ago

    California, United States Pacific Gas And Electric Company Full time

    Requisition ID# 157931 Job Category: Business Operations / Strategy Job Level: Director/Chief Business Unit: Gen Counsel, Ethics, Risk & Compliance Work Type: Hybrid Job Location: Oakland Position Summary Leads a diverse team for Corporate Secretary operations. This includes a variety of shareholder, corporate governance and legal matters and requires...

  • Director of Operations

    1 week ago

    California, United States Attivo Partners Full time

    Role Overview The Director of Operations supports the People & Talent and Operations teams by providing excellent customer service and support to Attivo’s employees. The position will manage the client engagement process, help streamline operations, and coordinate all company events. The successful candidates will have a focus on setting goals, developing...

  • Director, Operational Risk Oversight

    2 weeks ago

    California, United States Reinsurance Group of America Full time

    Global Risk Services’ mission is to partner with RGA’s global workforce to facilitate sound risk analysis for decision making to achieve RGA’s strategic and financial objectives. The Director, Operational Risk Oversightworks with Global Risk Services to lead and embed the operational risk management framework at the enterprise level. Responsibilities...

  • Associate Clinical Director/Adolescent Behavioral Health

    4 weeks ago

    Concord, California, United States Newport Healthcare Full time

    About Us:Newport Healthcare is a nationwide behavioral healthcare organization dedicated to transforming young lives through evidence-based care. To that end, we have assembled the best teen and young adult mental health treatment staff in the country, and we want you to join us. While our experts guide our clients to sustainable healing, our job is to...

  • Assistant Operations Director

    2 weeks ago

    California, United States 18 Reasons Full time

    Flexible start date Sept, 2024 About us: 18 Reasons is a nonprofit that increases food security through the power of home cooking. Our mission is to empower our community with the confidence and creativity needed to buy, cook, and eat good food every day. We offer food education programs to the community through two different channels. At our 18th Street...